(324 days)
Not Found
No
The summary describes a standard optical imaging system and its performance characteristics, with no mention of AI, ML, or related concepts like training/test sets for algorithmic development.
No
The device is an imaging tool used to visualize vessels and blood flow; it does not directly treat a disease or condition. Its purpose is diagnostic, aiding procedures rather than providing therapy itself.
Yes
The "Intended Use / Indications for Use" states that the device is indicated for use "as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovasculature before, during or after cranial diagnostic and therapeutic procedures". The key phrase "as an aid in the visualization" for "diagnostic and therapeutic procedures" implies its role in diagnosis. Furthermore, it creates images of the "internal microstructure of tissues". While it is used during therapeutic procedures, its primary function of visualization for diagnostic purposes classifies it as a diagnostic device.
No
The device description explicitly lists hardware components such as an optic scanner probe, endoscope, light source, photo-multiplier tube, and sterile probe sheath. The performance studies also include testing related to these hardware components (e.g., sterile probe sheath tear resistance, electrical safety, biocompatibility, sterility).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- cCeLL - In vivo Function: The cCeLL - In vivo is an in vivo device. It is placed in direct contact with tissue to create images of the internal microstructure of tissues. It uses fluorescence imaging with ICG dye, which is administered to the patient, but the imaging itself is performed directly on the living tissue, not on a specimen removed from the body.
The device's intended use and description clearly indicate it is used for direct visualization of tissues and blood flow within the body during surgical procedures, which is the hallmark of an in vivo device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The cCeLL - In vivo is an optic scanner probe placed in direct contact with tissue to create images of the internal microstructure of tissues and is indicated for use with indocyanine green (ICG) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovasculature before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection.
Product codes
GWG, OWN
Device Description
The cCeLL - In vivo is used to provide real-time endoscopic images of near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive, neurosurgery in adults.
The overall system includes a 6 mm Pixection ICG/NIR Endoscope (0°) for use in neurosurgery, a light source for emission of NIR illumination, a photo-multiplier tube capable of capturing NIR imaging, and a sterile probe sheath intended for maintaining a sterile barrier between the subject device and the patient. The cCeLL - In vivo can be used with any medical grade high definition (HD) monitor with a DVI-D or RGB input. The patient contacting components contact tissue or bone with a duration of less than 24 hours.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical imaging (fluorescence imaging)
Anatomical Site
cerebrovasculature; tissue
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing demonstrated that the subject device conforms to the recognized safety standards, design input specifications and intended use consistent with the predicate device.
Test: Image Sensitivity Analysis
Test Method Summary: Validate the device's ability to visualize cerebral microstructures and vascular systems, including tumor tissue, surrounding normal tissue, blood vessels using clinically relevant ICG concentrations in a small animal model.
Results: The study confirmed that the device effectively visualized cerebral microstructures and vascular systems across a range of clinically relevant ICG concentrations. PASS
Test: Image Comparison Analysis
Test Method Summary: Comparison of the fluorescence signal between the subject and predicate device, following ICG injection in a small animal model, was conducted to determine if the subject device performs equivalently to the predicate device in visualizing vessels of various sizes and changes in blood flow.
Results: The study confirmed that the subject device can visualize vessels of various sizes and changes in blood flow with image quality comparable to the predicate device, as assessed across users with a range of experience. PASS
Test: Detection Linearity
Test Method Summary: To verify the device's accuracy and reliability in capturing fluorescence intensity, detection linearity was assessed by measuring optical power and brightness at various increments for both the predicate and subject devices.
Results: The detection linearity test demonstrated equivalent performance to the predicate device. PASS
Test: Geometric Distortion
Test Method Summary: To verify the device's accuracy and reliability in capturing fluorescence intensity with respect to geometric distortion, the power was measured using an optical power meter and radial distortion was calculated from the acquired image. Performance testing conducted with the predicate and subject devices.
Results: The geometric distortion test demonstrated equivalent performance to the predicate device. PASS
Test: Dynamic Range
Test Method Summary: To verify the device's gradation performance in capturing fluorescence intensity across its dynamic range, optical power and brightness were set, fluorescent target removed and the dynamic range was calculated using the acquired image. Performance testing conducted with the predicate and subject devices.
Results: The dynamic range test demonstrated equivalent performance to the predicate device. PASS
Test: Illumination & Detection Uniformity
Test Method Summary: To verify the device's accuracy and reliability in capturing fluorescence intensity, illumination and detection uniformity, the average intensity of each fluorescent dot in the region of interest [diagnostic area] and the illumination uniformity were calculated using the acquired image. Performance testing conducted with the predicate and subject devices.
Results: Testing measuring illumination and detection uniformity demonstrated equivalent performance to the predicate device. PASS
Test: SNR & Sensitivity
Test Method Summary: To verify the device's sensing ability in capturing fluorescence intensity, images were acquired and the signal to noise ratio (SNR) and sensitivity were calculated. Performance testing conducted with the predicate and subject devices.
Results: SNR & sensitivity test demonstrated equivalent performance to the predicate device. PASS
Test: Video Latency
Test Method Summary: To verify the device's dynamic vision capability in capturing fluorescence intensity, video latency was assessed by recoding the initialization and stoppage of motion on the screen and calculating the latency. Performance testing conducted with the predicate and subject devices.
Results: The test results demonstrated equivalent performance to the predicate device. PASS
Test: Sterile Probe Sheath Tear Resistance
Test Method Summary: To verify the robustness of SPS (Sterile Probe Sheath) tear resistance of the SPS was tested for breaking strength at different join interfaces on aged samples.
Results: The test resutls demonstrated that the SPS can withstand forces greater than those expected during clinical use. PASS
Test: Electrical Safety / EMC
Test Method Summary: IEC 60601-1:2005 + A1:2012 + A2:2021 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1-2 : 2014 + A1:2020, Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Electromagnetic Compatibility
Results: PASS
Test: Software / Cybersecurity (Enhanced Level)
Test Method Summary: FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" issued June 14, 2023. FDA guidance's Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Postmarket Management of Cybersecurity in Medical Devices.
Results: PASS
Test: Biocompatibility
Test Method Summary: Per FDA's Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", the single use Sterile Probe Sheath (SPS) is categorized as an external communicating device in contact with tissue/bone/dentin for
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).
0
August 21, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
VPIX Medical, Inc. % Dawn N. Norman, M.S. Partner MRC Global, LLC 9085 E. Mineral Circle, Suite 110 Centennial, CO 80112
Re: K233391
Trade/Device Name: cCeLL - In vivo Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG, OWN Dated: July 18, 2024 Received: July 22, 2024
Dear Dawn Norman:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Adam D Pierce -S
Digitally signed by Adam D. Pierce -S Date: 2024.08.21 15:25:30 -04'00'
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices
2
OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233391
Device Name cCeLL - In vivo
Indications for Use (Describe)
The cCeLL - In vivo is an optic scanner probe placed in direct contact with tissue to create images of the internal microstructure of tissues and is indicated for use with indocyanine green (ICG) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovasculature before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
K233391 510(k) Summary
i. Submitter Information
ii.
iii.
| Submitter: | VPIX Medical, Inc. |
|---|---|
| 774, Gyeryong-ro, Jung-gu | |
| Daejeon, 34873 | |
| Republic of Korea | |
| Contact Person: | Kyungmin Hwang, President |
| Submitter: | Jin Hee Byon, RA Team Leader |
| Email: | julie.byon@vpixmedical.com |
| Phone: | +82 (0)42 535 0668 |
| Official Correspondent: | Dawn Norman, MS |
| Email: | dawn.norman@askmrcglobal.com |
| Phone: | 01-618-604-3064 |
| Date Prepared: | August 17, 2024 |
| Device Name | |
| Proprietary Name: | cCeLL - In vivo |
| Manufacturer: | VPIX Medical, Inc. |
| Common Name: | Neurological Endoscope |
| Classification Name: | Endoscope, Neurological |
| Regulation Number: | 21 CFR 882.1480; 21 CFR 876.1500 |
| Device Class: | Class II |
| Product Code: | GWG (Primary) |
| OWN (Secondary) | |
| Predicate Devices | |
| 510(k) Number: | K180146 |
| Proprietary Name: | KARL STORZ ICG Imaging System |
| Manufacturer | KARL STORZ Endoskopie-America, Inc. |
Manufacturer: Common Name: Classification Name: Regulation Number: Device Class: Product Code:
KARL STORZ Endoscopy-America, Inc. Neurological Endoscope Endoscope, Neurological 21 CFR 882.1480; 21 CFR 876.1500 Class II GWG, OWN
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iv. Device Description
The cCeLL - In vivo is used to provide real-time endoscopic images of near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive, neurosurgery in adults.
The overall system includes a 6 mm Pixection ICG/NIR Endoscope (0°) for use in neurosurgery, a light source for emission of NIR illumination, a photo-multiplier tube capable of capturing NIR imaging, and a sterile probe sheath intended for maintaining a sterile barrier between the subject device and the patient. The cCeLL - In vivo can be used with any medical grade high definition (HD) monitor with a DVI-D or RGB input. The patient contacting components contact tissue or bone with a duration of less than 24 hours.
V. Principle of Operation / Mechanism of Action
This product irradiates the tissue with a laser by contacting the probe to the suspected tumor site of a patient injected with indocyanine green. It is a medical fluorescence imaging device that measures the intensity of the fluorescence signal emitted from the tissue and images the cells of the tissue. It has a function to acquire an image of a part corresponding to an area of several hundred um of tissue at a depth of several to several hundred um by using fluorescence and shows a two-dimensional image through the provided software.
vi. Indications for Use
The cCeLL - In vivo is an optic scanner probe placed in direct contact with tissue to create images of the internal microstructure of tissues and is indicated for use with indocyanine green (ICG) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovasculature before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection.
vii. Summary of Substantial Equivalence
The similarities between subject device and predicate device are as follows: Both devices provide images of NIR Indocyanine green (ICG) dye fluorescence during minimally invasive, neurosurgery in adults.
Both can be used with any medical grade HD monitor with a DVI-D input.
The differences between subject device and predicate device are as follows:
The predicate also provides fluorescence during plastic, micro- and reconstructive surgical procedures in adults and pediatric populations. The predicate allows use of a medical grade HD monitor with 3G-SDI input. The predicate device is supplied with an ICG kit while the subject device is not.
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Substantial Equivalence Table:
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| 510(k) Number | K233391 | K180146 | N/A |
| Device | |||
| Identification | Trade Name: cCeLL - In vivo | ||
| Classification Name: Neurological Endoscope | Trade Name: KARL STORZ ICG Imaging System | ||
| Classification Name: Neurological Endoscope | N/A | ||
| Product Code | GWG, OWN | GWG, OWN | Identical |
| Regulation | 21 CFR 876.1480 | ||
| (Neurological Endoscope) | 21 CFR 876.1480 | ||
| (Neurological Endoscope) | Identical | ||
| Device | |||
| Description | The cCeLL - In vivo is used to provide real-time | ||
| high-definition (HD) endoscopic images of near- | |||
| infrared (NIR) indocyanine green (ICG) dye | |||
| fluorescence during minimally invasive, | |||
| neurosurgery in adults. |
The overall system includes a 6 mm Pixection
ICG/NIR Endoscope (0°) for use in
neurosurgery, a light source for emission of NIR
illumination, a photo-multiplier tube capable of
capturing NIR imaging, and a sterile probe
sheath. | The KARL STORZ ICG Imaging System is used to
provide real-time high-definition (HD)
endoscopic or telescopic images of visible (VIS)
and near-infrared (NIR) indocyanine green (ICG)
dye fluorescence during minimally invasive,
neuro- and endonasal skull base surgery as well
as plastic, micro- and reconstructive surgical
procedures in general and pediatric populations.
The overall system includes a 4mm HOPKINS
ICG/NIR Endoscope (0°, 30° or 45°) for use in
neuro- and endonasal skull base surgery, a 5mm
& 10mm HOPKINS ICG/NIR Endoscope (0° or
30°) for use in minimally invasive procedures
and a VITOM II ICG/NIR Telescope for use in
plastic, micro- and reconstructive surgical
procedures for VIS and NIR illumination and
imaging, a light source with foot switch for
emission of VIS and NIR illumination, a color
video camera head capable of capturing both
VIS and NIR imaging, and a KARL STORZ ICG Kit.
Additional accessories used with the KARL
STORZ ICG Imaging System include two
standards fiber-optic light cables for
transmission of VIS and NIR light and the
Image1 S Camera Control Unit (CCU). | Similarities
Both devices provide HD
images of NIR
Indocyanine green (ICG)
dye fluorescence during
minimally invasive,
neuro- and endonasal
skull base surgery in
adults.
Both can be used with
any medical grade HD
monitor with a DVI-D
input.
Differences
The predicate also
provides fluorescence
during plastic, micro-
and reconstructive
surgical procedures in
pediatric populations.
The predicate allows use
of a medical grade HD
monitor with 3G-SDI
input. |
| | Subject Device | Predicate Device | Comparison |
| | The cCeLL - In vivo can be used with any
medical grade HD monitor with a DVI-D or RGB
input. | The KARL STORZ ICG Imaging System can be
used with any medical grade HD monitor with a
DVI-D or 3G-SDI input. | The predicate device is
supplied with an ICG kit
while the subject device
is not. |
| Intended Use | The cCeLL - In vivo is intended to provide real-
time near-infrared fluorescence imaging. | The KARL STORZ ICG Imaging System is intended
to provide real-time visible and near-infrared
fluorescence imaging. | Identical except the
predicate provides
visible fluorescence
imaging. |
| Indications for
Use | The cCeLL - In vivo is an optic scanner probe
placed in direct contact with tissue to create
images of the internal microstructure of tissues
and is indicated for use with indocyanine green
(ICG) for fluorescence imaging as an aid in the
visualization of vessels (micro- and macro-
vasculature) blood flow in the
cerebrovasculature before, during or after
cranial diagnostic and therapeutic procedures,
such as tumor biopsy and resection. | The KARL STORZ Endoscopic ICG System enables
surgeons to perform minimally invasive surgery
using standard endoscopic visible light as well as
visual assessment of vessels, blood flow and
related tissue perfusion, or at least one of the
major extra-hepatic bile ducts (cystic duct,
common bile duct and common hepatic duct),
using near infrared imaging. Fluorescence
imaging of biliary ducts with the KARL STORZ
Endoscopic ICG System is intended for use with
standard of care white light and, when
indicated, intraoperative cholangiography. The
device is not intended for standalone use for
biliary duct visualization. | Similarities
Both use HD images of
NIR Indocyanine green
(ICG) dye fluorescence
during minimally
invasive, neuro- and
endonasal skull base
surgery in adults.
Both can be used with
any medical grade HD
monitor with a DVI-D
input. |
| | | Additionally, the KARL STORZ Endoscopic ICG
System enables surgeon to perform minimally
invasive cranial neurosurgery in adults and
pediatrics and endonasal skull base surgery in
adults and pediatrics > 6 years of age using
standard endoscopic visible light as well as
visual assessment of vessels, blood flow and
related tissue perfusion using near infrared
imaging.
The KARL STORZ VITOM II ICG System is
intended for capturing and viewing fluorescent
images for the visual assessment of blood flow, | Differences
The predicate is
indicated for pediatrics
cranial neurosurgery and
endonasal skull base
surgery in adults and
pediatrics > 6 years of
age.
The predicate has
multiple light and
visualization options.
The predicate also |
| | | as an adjunctive method for the evaluation of | The predicate also |
| | Subject Device | Predicate Device | Comparison |
| | | tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light. | provides fluorescence during plastic, micro- and reconstructive surgical procedures in general and pediatric populations.
The predicate allows use of a medical grade HD monitor with 3G-SDI input. |
| | The cCeLL - In vivo includes the following components and accessories: | The KARL STORZ ICG Imaging System includes the following components and accessories: | Similarities
Both devices use a camera and optical fiber light source to process images. |
| | Main Unit
(for NIR illumination and capturing) Pixection (for endoscope) Sterile Probe Sheath | 4mm, 5mm & 10mm HOPKINS ICG/NIR Endoscopes VITOM II ICG Telescope Camera Head (H3Z-FI) Fiber optic Light Cables Light Source Image1 S CCU | |
| Technological
Characteristics | The Pixection is intended to be connected to the Main Unit, which connects to the PC for image processing, as well as to the light source via optical fiber as the source of illumination to allow visualization of internal anatomy. Visualization and navigation is performed using NIR imaging for visual assessment and/or confirmation of vessels, blood flow or tissue perfusion is desired. | The endoscopes/telescope are intended to be connected to the optical coupler of the camera head, which connects to the CCU for image processing, as well as to the light source via compatible light cable as the source of illumination to allow visualization of internal anatomy. Visualization and navigation is performed initially using VIS imaging. NIR imaging is selected when visual assessment and/or confirmation of vessels, blood flow or tissue perfusion is desired. | Differences
The predicate uses VIS while the subject device uses NIR for Visualization and navigation. |
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8
9
viiii. Performance Testing
Verification and validation testing demonstrated that the subject device conforms to the recognized safety standards, design input specifications and intended use consistent with the predicate device.
| Test | Test Method Summary | Results |
|---|---|---|
| Image Sensitivity | ||
| Analysis | Validate the device's ability to visualize cerebral microstructures and | |
| vascular systems, including tumor tissue, surrounding normal tissue, blood | ||
| vessels using clinically relevant ICG concentrations in a small animal model. | The study confirmed that the device effectively | |
| visualized cerebral microstructures and vascular | ||
| systems across a range of clinically relevant ICG | ||
| concentrations. PASS | ||
| Image | ||
| Comparison | ||
| Analysis | Comparison of the fluorescence signal between the subject and predicate | |
| device, following ICG injection in a small animal model, was conducted to | ||
| determine if the subject device performs equivalently to the predicate | ||
| device in visualizing vessels of various sizes and changes in blood flow. | The study confirmed that the subject device can | |
| visualize vessels of various sizes and changes in | ||
| blood flow with image quality comparable to the | ||
| predicate device, as assessed across users with a | ||
| range of experience. PASS | ||
| Detection | ||
| Linearity | To verify the device's accuracy and reliability in capturing fluorescence | |
| intensity, detection linearity was assessed by measuring optical power and | ||
| brightness at various increments for both the predicate and subject | ||
| devices. | The detection linearity test demonstrated | |
| equivalent performance to the predicate device. | ||
| PASS | ||
| Geometric | ||
| Distortion | To verify the device's accuracy and reliability in capturing fluorescence | |
| intensity with respect to geometric distortion, the power was measured | ||
| using an optical power meter and radial distortion was calculated from the | ||
| acquired image. Performance testing conducted with the predicate and | ||
| subject devices. | The geometric distortion test demonstrated | |
| equivalent performance to the predicate device. | ||
| PASS | ||
| Dynamic Range | To verify the device's gradation performance in capturing fluorescence | |
| intensity across its dynamic range, optical power and brightness were set, | ||
| fluorescent target removed and the dynamic range was calculated using | ||
| the acquired image. Performance testing conducted with the predicate and | ||
| subject devices. | The dynamic range test demonstrated equivalent | |
| performance to the predicate device. PASS | ||
| Illumination & | ||
| Detection | ||
| Uniformity | To verify the device's accuracy and reliability in capturing fluorescence | |
| intensity, illumination and detection uniformity, the average intensity of | ||
| each fluorescent dot in the region of interest [diagnostic area] and the | Testing measuring illumination and detection | |
| uniformity demonstrated equivalent performance | ||
| to the predicate device. PASS | ||
| Test | Test Method Summary | Results |
| illumination uniformity were calculated using the acquired image. | ||
| Performance testing conducted with the predicate and subject devices. | ||
| SNR & | ||
| Sensitivity | To verify the device's sensing ability in capturing fluorescence intensity, | |
| images were acquired and the signal to noise ratio (SNR) and sensitivity | ||
| were calculated. Performance testing conducted with the predicate and | ||
| subject devices. | SNR & sensitivity test demonstrated equivalent | |
| performance to the predicate device. PASS | ||
| Video Latency | To verify the device's dynamic vision capability in capturing fluorescence | |
| intensity, video latency was assessed by recoding the initialization and | ||
| stoppage of motion on the screen and calculating the latency. Performance | ||
| testing conducted with the predicate and subject devices. | The test results demonstrated equivalent | |
| performance to the predicate device. | ||
| PASS | ||
| Sterile Probe | ||
| Sheath Tear | ||
| Resistance | To verify the robustness of SPS (Sterile Probe Sheath) tear resistance of the | |
| SPS was tested for breaking strength at different join interfaces on aged | ||
| samples. | The test resutls demonstrated that the SPS can | |
| withstand forces greater than those expected | ||
| during clinical use. PASS | ||
| Electrical Safety | ||
| / EMC | IEC 60601-1:2005 + A1:2012 + A2:2021 Medical electrical equipment – Part | |
| 1: General requirements for basic safety and essential performance | ||
| IEC 60601-1-2 : 2014 + A1:2020, Medical Electrical Equipment - Part 1-2: | ||
| General requirements for basic safety and essential performance - | ||
| Electromagnetic Compatibility | PASS | |
| Software / | ||
| Cybersecurity | ||
| (Enhanced Level) | FDA's Guidance for Industry and FDA Staff, "Content of Premarket | |
| Submissions for Device Software Functions" issued June 14, 2023. | ||
| FDA guidance's Cybersecurity in Medical Devices: Quality System | ||
| Considerations and Content of Premarket Submissions, Postmarket | ||
| Management of Cybersecurity in Medical Devices. | PASS | |
| Biocompatibility | Per FDA's Guidance "Use of International Standard ISO 10993-1, "Biological | |
| evaluation of medical devices - Part 1: Evaluation and testing within a risk | ||
| management process", the single use Sterile Probe Sheath (SPS) is | ||
| categorized as an external communicating device in contact with | ||
| tissue/bone/dentin for |